Numerous commentaries from medical experts agree with Dr. Olan. They criticize Kallmes et al and Buchbinder et al for including patients with sub-acute and chronic fractures up to a year old, inconsistent use of the evidence of bone edema on MRI as an inclusion criteria, selection bias, statistical power of the sample size, the absence of a control group that did not get an intervention, and the high crossover from placebo to vertebroplasty.
A more rigorous study, says Dr. Olan, is "Vertebroplasty vs. Conservative Treatment in Osteoporotic Vertebral Compression Fractures" (VERTOS II), published recently in The Lancet.
VERTOS II is the largest, peer-reviewed study of vertebroplasty to date. In it, 202 patients with acute fractures confirmed by edema on MRI were randomly allocated to receive either vertebroplasty or conservative medical therapy. Patients receiving vertebroplasty had greater pain relief – as measured on a visual analog scale (VAS) – from the first day after the procedure to one year later than those treated conventionally. From baseline, the reductions in pain were 5.2 at 1 month and 5.7 at 1 year. Pain reductions in the control group were less substantial at 2.7 at 1 month and 3.7 at 1 year.
"Randomized, placebo-controlled trials provide only an approximation of the truth. Information from observational outcome studies is also important because patients and physicians in the real world don't always behave like those in clinical trials," says Dr. Olan.
"As physicians we need to weigh study results against our own experience. VERTOS II and the countless patients I've treated who have benefitted from vertebroplasty validate this procedure's efficacy."
In addition to his practice, Dr.
|SOURCE Wayne J. Olan|
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